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Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)
ClinicalTrials.gov; 30/09/2020; TrialID: NCT04575597
Clinical Trial Register | ICTRP | ID: ictrp-NCT04575597
ABSTRACT

Condition

Coronavirus Disease (COVID-19)

Intervention

Drug Molnupiravir;Drug Placebo

Primary 

outcome:

Percentage of participants who are hospitalized and/or die;Percentage of participants with an adverse event (AE);Percentage of participants who discontinued study intervention due to an AE

Criteria


Inclusion Criteria

- Has documentation of laboratory confirmed severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) infection with sample collection =5 days prior to the day
of randomization. PCR is the preferred method; however with evolving approaches to
laboratory confirmation of SARS-CoV-2 infection, other molecular or antigen tests that
detect viral ribonucleic acid (RNA) or protein are allowed if authorized for use in
the country. Serological tests that detect host antibodies generated in response to
recent or prior infection are not allowed.

- Had initial onset of signs/symptoms attributable to COVID-19 for =5 days prior to the
day of randomization and at least 1 of the following sign/symptom attributable to
COVID-19 on the day of randomization.

- Has mild or moderate COVID-19.

- Has at least 1 characteristic or underlying medical condition associated with an
increased risk of severe illness from COVID-19.

- Males agree to the following during the intervention period and for at least 4 days
after the last dose of study intervention Either abstain from heterosexual
intercourse as their preferred and usual lifestyle (abstinent on a long term and
persistent basis) and agree to remain abstinent; or must agree to use contraception.

- Females are not pregnant or breastfeeding, and at least one of the following
conditions applies Is not a woman of child bearing potential (WOCBP); or is a WOCBP
and using a contraceptive method that is highly effective (a low user dependency
method OR a user dependent method in combination with barrier method), or be abstinent
from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a
long-term and persistent basis) for at least 4 days after the last dose of study
intervention; a WOCBP must have a negative highly sensitive pregnancy test (urine or
serum test is required) within 24 hours before the first dose of study intervention.

Exclusion Criteria

- Is currently hospitalized or is expected to need hospitalization for COVID-19 within
48 hours of randomization.

- Is on dialysis or has reduced estimated glomerular filtration rate (eGFR) <30
mL/min/1.73m^2 by the Modification of Diet in Renal Disease (MDRD) equation.

- Has any of the following conditions human immunodeficiency virus (HIV) with a recent
viral load >50 copies/mL (regardless of CD4 count) or an AIDS-defining illness in the
past 6 months, participants with HIV may only be enrolled if on a stable
antiretroviral therapy regimen; a neutrophilic granulocyte absolute count <500/mm^3.

- Has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis,
end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST)
and/or alanine aminotransferase (ALT) >3X upper limit of normal at screening.

- Has a platelet count <100,000/µL or received a platelet transfusion in the 5 days
prior to randomization.

- Is taking or is anticipated to require any prohibited therapies.

- Is unwilling to abstain from participating in another interventional clinical study
through Day 29 with an investigational compound or device, including those for
COVID-19 therapeutics.

- Has hypersensitivity or other contraindication to any of the components of the study
interventions as determined by the investigator.

- Has any condition for which, in the opinion of the investigator, participation would
not be in the best interest of the participant or that could prevent, limit, or
confound the protocol-specified assessments including but not limited to participants
who are not expected to survive longer than 48 hours after randomization, or
participants with a recent history of mechanical ventilation, or participants with
conditions that could limit gastrointestinal absorption of capsule contents.


Collection: Clinical trial registers Database: ICTRP Topics: Long Covid / Vaccines Year: 2020 Document Type: Clinical Trial Register

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Collection: Clinical trial registers Database: ICTRP Topics: Long Covid / Vaccines Year: 2020 Document Type: Clinical Trial Register